This is a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective is to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.
Active, not recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Atezolizumab | MPDL3280A; RO5541267 | Atezolizumab |
This is a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab in participants with treatment-naive locally advanced or metastatic NSCLC. In addition, the primary biomarker objective is to evaluate various predictive cutoffs for novel blood-based diagnostic assays.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Atezolizumab | Experimental | Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression or loss of clinical benefit (up to approximately 28 months). |
|
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed Stage IIIB-IVB NSCLC
- Measurable disease per RECIST v1.1
- Adequate hematologic and end-organ function
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods among women of childbearing potential
Exclusion Criteria:
- Prior treatment with immunotherapy or chemotherapy for any stage NSCLC, including early-stage (neoadjuvant or adjuvant) disease
- Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and anaplastic lymphoma kinase (ALK) rearrangements
- Active central nervous system (CNS) metastases requiring treatment
- Spinal cord compression not definitively treated or not clinically stable
- Leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
- Uncontrolled or symptomatic hypercalcemia
- Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
- Pregnant or lactating women
- History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease
- Positive human immunodeficiency virus (HIV) or hepatitis B or C
- Active tuberculosis
- Severe infection or major surgery within 4 weeks, or antibiotic treatment for acute infection within 2 weeks prior to randomization
- Prior treatment with or hypersensitivity to study drug or related compounds
- Prior allogeneic bone marrow or solid organ transplant
- Receipt of a live attenuated vaccine within 4 weeks prior to randomization
- Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
- Treatment with systemic corticosteroids within 2 weeks prior to randomization
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Both |
| Healthy Volunteers: | No |
| Measure: | Percentage of Participants With Objective Response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator |
| Time Frame: | Up to approximately 28 months |
| Safety Issue: | No |
| Description: |
| Measure: | PFS per RECIST v1.1 as Determined by Investigator |
| Time Frame: | Up to approximately 28 months |
| Safety Issue: | No |
| Description: |
| Measure: | Duration of Response (DOR) per RECIST v1.1 as Determined by Investigator |
| Time Frame: | Up to approximately 28 months |
| Safety Issue: | No |
| Description: |
| Measure: | Overall Survival (OS) |
| Time Frame: | From baseline until death (Up to approximately 28 months) |
| Safety Issue: | No |
| Description: |
| Measure: | Percentage of Participants With Adverse Events |
| Time Frame: | Up to approximately 28 months |
| Safety Issue: | No |
| Description: |
| Measure: | Percentage of Participants Who Were Alive and Progression-free (PFS) at 6, 9, and 12 Months by Blood-based Tumor Biomarkers |
| Time Frame: | Months 6, 9, and 12 |
| Safety Issue: | No |
| Description: |
| Measure: | Percentage of Participants Who Were Alive (OS) at 6, 9, and 12 Months by Blood-based Tumor Biomarkers |
| Time Frame: | Months 6, 9, and 12 |
| Safety Issue: | No |
| Description: |
